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Diagnostica Stago, Inc.

Diagnostica Stago, Inc. Recalls

All product recalls associated with Diagnostica Stago, Inc..

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Recall Summary

Total Recalls

475

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 461–475 of 475 recalls

Diagnostica Stago, Inc.: STA Liatest Free Protein S, cat. 00516. These kits are i...

The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range.

FDAOct 26, 2005Nationwide• Diagnostica Stago, Inc.

Louisville Apl Diagnostics Inc: APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distribute...

Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.

FDAOct 6, 2005CA, FL, GA +1 more• Louisville Apl Diagnostics Inc

Louisville Apl Diagnostics Inc: APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; dist...

Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.

FDA

1...22 2324

Page 24 of 24Next

Oct 6, 2005

CA, FL, GA +1 more

• Louisville Apl Diagnostics Inc

Louisville Apl Diagnostics Inc: APhL HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G; distribute...

Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.

FDAOct 6, 2005CA, FL, GA +1 more• Louisville Apl Diagnostics Inc

Diagnostica Stago, Inc.: STA-R blood coagulation analyzer. Catalog Number 57160.

Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process.

FDAJun 20, 2005Nationwide• Diagnostica Stago, Inc.

Diagnostica Stago, Inc.: PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Dia...

Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.

FDAApr 13, 2005Nationwide• Diagnostica Stago, Inc.

Chembio Diagnostic System Inc: OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregn...

Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functional testing and noticed a degradation in performance of the two lots. Chembio's investigation revealed invalid results (no control lines) and some false negatives.

FDAOct 6, 2004FL, IN, KS +8 more• Chembio Diagnostic System Inc

ABX Diagnostics Inc: Automated Differential Cell Counter

Device can generate overestimated platelet results.

FDAAug 13, 2004Nationwide• ABX Diagnostics Inc

Louisville Apl Diagnostics Inc: american diagnostica inc. IgG Conjugate, 15mL; component ...

Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.

FDAAug 10, 2004CT, IN• Louisville Apl Diagnostics Inc

Louisville Apl Diagnostics Inc: american diagnostica inc. IgM Conjugate, 15mL; component ...

Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.

FDAAug 10, 2004CT, IN• Louisville Apl Diagnostics Inc

ABX Diagnostics Inc: PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

Power failure having impact on software.

FDAJun 24, 2004Nationwide• ABX Diagnostics Inc

ABX Diagnostics Inc: Pentra 80 and Pentra 80XL Hematology Analyzers

Software defect, instrument may erroneously give a result of '0' or '---'.

FDAApr 8, 2004Nationwide• ABX Diagnostics Inc

Watson Diagnostics Inc.: Papsure, Speculite, Disposable light for vaginal illumina...

Lights split, spilling contents when bent to activate.

FDAAug 7, 2003Nationwide• Watson Diagnostics Inc.

ABX Diagnostics Inc: ABX Diagnostices Pentra 60C+ Hematology Analyzer

Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.

FDAJun 4, 2003Nationwide• ABX Diagnostics Inc

Diagnostica Stago, Inc.: STA-Compact Hemostasis System with Cap piercing capability.

With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.

FDAMar 5, 2003Nationwide• Diagnostica Stago, Inc.