i-STAT CK-MB cartridge Abbott Point of Care, Princeton, NJ 08540
This recall has been terminated (originally issued November 3, 2010).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- January 1, 2008
- Posted
- November 3, 2010
- Terminated
- September 14, 2011
- Recall Number
- Z-0318-2011
- Quantity
- 482,500 (total)
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.
Distribution
Worldwide Distribution: USA and Canada.
Lot / Code Info
06F25-01; 06F25-02; This product has various expiration dates. All products have expired.
Root Cause
Other
Action Taken
Abbott Point Of Care Inc.sent notification letters with a customer reply form to all affected customer in January, 2008. All distributors outside the US who were sent shipments from the affected lots were notified of the lot numbers that were affected. Affected product is to be quarantined and returned for replacement. Customers with questions about this recall can contact Abbott Point Of Care at 609 454-9000.