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Showing 21141–21160 of 22584 results

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Dade Behring Inc. Rte 896, Glasgow Business Community: DispoSystem for BCT System.Model number OVFR03. Multipurp...

APTT determinations when using affected rotors may lead to incorrectly shortened times

FDAAug 27, 2004Nationwide• Dade Behring Inc. Rte 896, Glasgow Business Community

Abbott Laboratories HPD/ADD/GPRD: Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tes...

There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots.

FDAAug 27, 2004Nationwide• Abbott Laboratories HPD/ADD/GPRD

Linvatec Corp.: Ultra Power Burs, Sterile, Single-Use.

The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.

FDAAug 26, 2004Nationwide• Linvatec Corp.

Abbott Health Products, Inc.: AxSYM Total B-hCG Reagent, Product list number: 7A59-22 a...

Assay may give elevated patients results.

FDAAug 24, 2004Nationwide• Abbott Health Products, Inc.

Hill-Rom, Inc.: Hill-Rom brand VersaCare Bed; Model P3200.

Pivot bolts on the sleep deck may become loose and fall out, allowing the head section to shift or to drop to one side, and a grounding warning label is missing.

FDAAug 24, 2004Nationwide• Hill-Rom, Inc.

Zimmer Spine, Inc.: ATO Drill Guide Kit (All Through One Drill Guides Set), m...

To date, there has been one complaint reported. During a Trinica surgical case, the surgeon was provided a standard disposable, Trinica Drill Bit (part number 07.00166.001) for use with the Trinica All Through One Drill Guide Instrumentation, instead of the ALL Through One Drill Bit. This enabled the physician to drill a few millimeters further than expected.

FDAAug 24, 2004Nationwide• Zimmer Spine, Inc.

Toshiba American Med Sys Inc: Magnetic Resonance Imaging Systems, under the following n...

Software defect causes patient identification number to be truncated.

FDAAug 24, 2004Nationwide• Toshiba American Med Sys Inc

Medtronic Inc, Neurological & Spinal Division: 8870 software application card versions AAA 02, BBB 04, B...

With the Model 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N'Vision Clinician Programmer, users may have mistakenly entered a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. This issue is limited to programming the SynchroMed and SynchroMed EL pumps.

FDAAug 24, 2004IN• Medtronic Inc, Neurological & Spinal Division

Nellcor Puritan Bennett: The probes involved have been part of the Nellcor CapnoPr...

The product is contaminated with Burkholderia cepacia (formally known as Pseudomonas cepacia), based on the Texas Health Department analysis and also firm's analysis.

FDAAug 24, 2004IN• Nellcor Puritan Bennett

bioMerieux: Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Caro...

Complaints were received from the field regarding prolonged clot times, high control values and erratic results.

FDAAug 20, 2004Nationwide• bioMerieux

Roche Diagnostics Corp.: Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the R...

Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.

FDAAug 20, 2004Nationwide• Roche Diagnostics Corp.

Philips Medical Systems Sales & Service Region No. America: NT Intera Magnetic Resonance Image System

Potential for patient burn

FDAAug 20, 2004Nationwide• Philips Medical Systems Sales & Service Region No. America

Becton Dickinson & Company: BD Vacutainer Partial Draw serum tubes (with or without g...

"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and a

FDAAug 20, 2004Nationwide• Becton Dickinson & Company

bioMerieux: MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North ...

Complaints were received from the field regarding prolonged clot times, high control values and erratic results.

FDAAug 20, 2004Nationwide• bioMerieux

Roche Diagnostics Corp.: Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the R...

Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.

FDAAug 20, 2004Nationwide• Roche Diagnostics Corp.

Becton Dickinson & Company: BD Vactuainer SST glass and plastic tubes.

"Please be aware tht this not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and adrenal gland function. The immunoassay results are high when

FDAAug 20, 2004Nationwide• Becton Dickinson & Company

Becton Dickinson & Company: BD Vacutainer Microtainer Serum tubes (with or without gel).

"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and

FDAAug 20, 2004Nationwide• Becton Dickinson & Company

Abbott Laboratories HPD/ADD/GPRD: ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and ...

Changes in the ARCHITECT B12 Reagent lots may adversely affect the shape of the calibration curve, over time. These changes may produce controls out of range low and similar decreases in patient sample values prior to current expiration of the reagents.

FDAAug 19, 2004Nationwide• Abbott Laboratories HPD/ADD/GPRD

Unknown Manufacturer: Hem-o-lok Endo5 Ligation Applier

The jaws may break during clip loading or clip application.

FDAAug 18, 2004Nationwide

Ross Products Division Abbott Laboratories: Flexiflo Quantum Enteral Pump

Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.

FDAAug 18, 2004Nationwide• Ross Products Division Abbott Laboratories

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