BioFire Diagnostics FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire recall — FDA Z-1242-2019
Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World…
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.
Product mislabeling.
The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time.…
Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World…
Intermittent heat seal failures on the outer pouch of some EZ Derm products.
The target values and ranges in these lots are incorrect.
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one…
Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World…
The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to…
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a…
Scallop flavor used in the product contains low levels of crustaceans (1 ppm) that is not listed on the product label.
WAWA has initiated a recall of Wawa Iced Tea Less Sugar, Net weight/number of units per package: 12 FL OZ. , Package type: Bottle Units per case: 24, Expiration date: April 29, 2019…
Formed Potato Tater Puffs (H30 s), sold as a foodservice item, are recalled due to contamination with plastic object.
Microbial contamination with Bacillius circulans and Bacillus cereus / thuringiensis / mycoides.
Firm is voluntarily recalling specific lots of Harmless Harvest s Dairy-Free Yogurt Drink beverages after identifying a possible packaging defect that may result in premature spoilage
Firm is voluntarily recalling specific lots of Harmless Harvests Dairy-Free Yogurt Drink beverages after identifying a possible packaging defect that may result in premature spoilage
Stanganellis Italian Foods, is initiating a recall of Pumpkin Cake Roll, Net Wt. 24 oz. . One per package, because of product miss-labeling. The firm inadvertently left off the allergen…
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