FDA (Devices) recall action 91148
The FDA (Devices) publishes a recall like this one as 94 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 94 pages.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Biomerieux is recalling API NIT1 NIT2 Reagents (Catalog 70442, Batch 1009326520) distributed nationwide due to storage conditions that exceeded temperature and time parameters, preventing guaranteed product performance.
Biomerieux is recalling ETEST Clinical Tobramycin susceptibility test strips (batch 1009434160) because temperature and storage time conditions were exceeded during distribution. Product performance cannot be guaranteed due to these storage failures.
Biomerieux Inc. recalls 58 units of the VITEK 2 AST-XN15 Test Kit after storage temperatures exceeded safe limits. Performance cannot be guaranteed. Nationwide US distribution.
Biomerieux Inc. is recalling PPM CLINICAL CHROMID STREPTO B diagnostic media (batch 1009534170) because storage temperature and time exceeded specified limits, preventing assurance of product performance.
Biomerieux Inc is recalling 7 units of ETEST Clinical Vancomycin VA 256 test kits due to storage temperature excursions that may compromise test performance. Affected kits were distributed nationwide.
A batch of VITEK 2 Reagent BCL Test Kit from Biomerieux Inc is being recalled because storage conditions were exceeded, and product performance cannot be guaranteed.
Biomerieux is recalling a C. difficile diagnostic test kit after units were stored outside temperature and time limits, potentially compromising test performance.
Biomerieux recalled ETEST vancomycin susceptibility tests after storage temperature and time excursions that may compromise product reliability and test accuracy.
Biomerieux Inc is recalling API VP1 VP2 reagents (Catalog 70422) nationwide because storage temperature and time limits were exceeded, preventing the manufacturer from guaranteeing product performance.
Biomerieux Inc is recalling API JAMES 2AMP clinical diagnostic devices due to improper temperature and time storage conditions that may affect product performance. Affected units nationwide should not be used.
Biomerieux Inc recalls ETEST Clinical Benzylpenicil susceptibility test kits due to temperature and time excursions during storage that affect product performance. Batch 1009477980 was distributed nationwide.
Biomerieux is recalling one batch of Nephrocheck Liquid Control Reagent because the product was stored outside proper temperature and time parameters, making performance unreliable.
Biomerieux Inc. is recalling PPM Lombard culture medium because the product was exposed to temperature and time conditions outside specification, potentially affecting test performance.
Biomerieux Inc is recalling the BIOBALL P.AERUGINOSA NCTC 12924 quality control product due to temperature and time excursions that may affect product performance. Two units with batch number 7240 were distributed nationwide.
Biomerieux Inc is recalling ETEST Clinical Erythromycin EM 256 US S30 test plates (batch 1009157090) distributed nationwide. Product performance cannot be guaranteed due to temperature and time storage conditions that exceeded specifications.
Biomerieux Inc. is recalling ETEST CLINICAL FLUCONAZOLE FL 256 susceptibility testing kits due to storage temperature and time excursions that prevent performance verification. Affected batch 1009172020 is distributed nationwide.
Biomerieux Inc is recalling PREVI COLOR GRAM diagnostic reagent (Catalog 29586) distributed nationwide because improper storage conditions may have degraded product performance.
Biomerieux Inc is recalling 14 units of the VITEK 2 REAGENT YST TEST KIT distributed nationwide because temperature and time excursions during storage may compromise the kit's performance.
Biomerieux is recalling VIDAS Progesterone 60 diagnostic tests (Batch 1009375960) nationwide due to storage temperature and time conditions being exceeded, preventing guaranteed product performance.