Z-0318-2011
i-STAT CK-MB cartridge Abbott Point of Care, Princeton, NJ 08540
Abbott Medical / initiated 2008-01-01 / Terminated / root cause: labeling and UDI
Abbott Point Of Care Inc. began a recall of i-STAT CK-MB cartridge Abbott Point of Care, Princeton, NJ 08540 on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0318-2011
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Abbott Medical
- Product
- i-STAT CK-MB cartridge Abbott Point of Care, Princeton, NJ 08540
- Product code
- CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- 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.
- Root cause tag
- labeling and UDI
- FDA root cause
- Other
- Action
- 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.
- Quantity in commerce
- 482,500 (total)
- Distribution
- Worldwide Distribution: USA and Canada.
- Product codes and lots
- 06F25-01; 06F25-02; This product has various expiration dates. All products have expired.
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