Recall Z-0020-2014 ยท CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Abbott Laboratories, Inc
Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
| Date | Oct 17, 2013 (initiated Aug 12, 2013) |
| Status | Terminated |
| Reason | Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier. |
| Root cause | Error in labeling |
| Action | The firm, Abbott Laboratories, sent a "PRODUCT CORRECTION" letter dated August 12, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to update existing inventory and manually track the implanted lots with the corrected expiration dates listed in the letter; retain a copy of letter and if you have forwarded any of the lots listed to another laboratory, provide a copy of the letter to them. If you or any of your healthcare providers you serve have any questions regarding this information, U.S. Customers please contact Custo |
| Quantity | 7213 |
| Distribution | Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Austria, Australia, Azerbaijan, Bangladesh, Bahamas, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Burkina, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Curacao, Cyprus, Czech |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981759 | PHOS Abbott Laboratories, Jun 16, 1998 |