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Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila

Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila Recalls

All product recalls associated with Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila.

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Recall Summary

Total Recalls

970

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 701–720 of 970 recalls

Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila: AxSYM Quinidine Controls - are composed of 3 bottles of c...

Controls Out of Range/Specification .

FDAMay 31, 2007AZ, AR, CA +29 more• Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila

Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila: XSYSTEMS Quinidine Calibrators consists of six bottles of...

Controls Out of Range/Specification.

FDAMay 31, 2007AZ, AR, CA +29 more• Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila

Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila: AxSYM Quinidine Standard Calibrators - consist of six bot...

Controls Out of Range/Specification .

FDAMay 31, 2007AZ, AR, CA +29 more• Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila

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Ortho-Clinical Diagnostics: VITROS 5,1 FS (Fusion Series) Chemistry System Software V...

Software design. The firm received a customer complaint regarding a qualitative positive THC (Cannabinoids) result obtained from a THC quality control fluid that was known to be negative when using VITROS Chemistry Products THC Reagent. A second customer complaint was received a month later. OCD's investigation concluded that under specific circumstances, incorrect qualitative results for Cannabi

FDAMay 17, 2007Nationwide• Ortho-Clinical Diagnostics

Roche Diagnostics Corp.: Roche Cortisol reagent for use in conjunction with Roche ...

The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.

FDAMay 15, 2007Nationwide• Roche Diagnostics Corp.

Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila: Architect AUSAB Calibrators IVD - list number 1L82-01 has...

During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to 53% higher than the WHO assigned value. This has the potential to cause elevated results and may impact the interpretation for a small percentage of results with grayzone or low-level reactive concentrations and higher proficiency sample results.

FDAMay 14, 2007Nationwide• Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila

Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila: ARCHITECT AUSAB Reagent list number 1L82-25 has the follo...

FDAMay 14, 2007Nationwide• Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila

Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila: ARCHITECT AUSAB Controls list number 1L82-10 have two bot...

FDAMay 14, 2007Nationwide• Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila

Roche Diagnostics Corp.: MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Vo...

False Positive Results: Product labeling states cross contamination is not an issue for high viral load titer samples, but the firm has determined that a potential sample contamination may not be detected at these levels and could result in false positive results being reported.

FDAMay 14, 2007Nationwide• Roche Diagnostics Corp.

Diagnostica Stago, Inc.: STA Liatest Free Protein S For in vitro diagnostic use. 2...

Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.

FDAMay 8, 2007Nationwide• Diagnostica Stago, Inc.

Humagen Fertility Diagnostics, Inc.: IVF Pasteur Pipettes, glass, cotton plugged, length 9", ...

Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.

FDAMay 8, 2007IL, IN• Humagen Fertility Diagnostics, Inc.

Meretek Diagnostics, Inc.: BreathTek Urea Hydrolysis Rate Calculation CD, Version 1....

Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.

FDAMay 2, 2007Nationwide• Meretek Diagnostics, Inc.

Roche Diagnostics Corp.: Roche VANC2, Online TDM Vancomycin, for use with the Roch...

Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.

FDAApr 30, 2007Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche VALP2, Online TDM Valproic acid , for use with the ...

FDAApr 30, 2007Nationwide• Roche Diagnostics Corp.

Ortho-Clinical Diagnostics: VITROS Immunodiagnostic Products Troponin I Reagent Pack,...

Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in the device failing to detect myocardial injury.

FDAApr 27, 2007Nationwide• Ortho-Clinical Diagnostics

Roche Diagnostics Corp.: Roche PTH (parathyroid hormone test system) for use in co...

Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.

FDAApr 19, 2007Nationwide• Roche Diagnostics Corp.

Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila: IMx Theophylline Reagent Pack (List 1A81-20) In Vitro tes...

A decrease in mP values (calibration curve Net Polarization value) has been observed with this reagent lot at all calibrator levels and may produce the following results: Calibration Error Code 148 (Polarization Too Small), Calibration Error Code 172 (Calibration Not Stored or Calibration Not Accepted) Controls out of range (when using a stored calibration curve).

FDAApr 11, 2007CA, IL, MA +5 more• Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila

Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila: Total B-hCG Speciment Diluent is composed of 1 bottle of ...

An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background effect is magnified potentially yelding false positive results for pregnancy and or Dilution Inaccuracy.

FDAApr 10, 2007PR• Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila

Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila: AxSYM Total B-hCG Reagent List 7A59-21 is composed of one...

FDAApr 10, 2007PR• Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila

Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila: IMx Total B-hCG Reagent is composed of one bottle of Anti...

FDAApr 10, 2007PR• Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila