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Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Potential contamination with Salmonella
Undeclared allergens (Peanut) due to mispackaging
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Presence of Foreign Tablets/Capsules
Subpotent product:out of specification assay results observed during long term stability testing.
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Butyrate tube cracks during actuation, rendering product unusable.
Product may contain food-grade cleaning agents
possible salmonella
The devices may have a misaligned thickness control bar.
Ophthalmic procedure packs may have incomplete seals affecting sterility.
A certain component of affected devices was not delivered within specification and contained impurities.