Recall Z-2405-2008 ยท LDP Colorimetry, Acetaminophen
Beckman Coulter Inc
Synchron Acetaminophen (ACTM) Reagent, Part Number 472169. ACTM Reagent when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 Systems and SYNCHRON Systems Drug Calibrator 2 set, is intended for quantitative determination of Acetaminophen concentration in human serum or plasma.
| Date | Sep 25, 2008 (initiated Jul 10, 2008) |
| Status | Terminated |
| Reason | This recall was initiated after Beckman Coulter verified through testing that Acetaminophen reagents (lots #M702524 & M703276) manufactured with contaminated heparin has shown a negative bias in performance between the assay made with contaminated and uncontaminated heparin. |
| Root cause | Process control |
| Action | The initial customer notifications with fax back response forms were mailed via US Postal Service beginning on 07/21/2008. The letter asked their customers to please discontinue use and discard appropriately the affected lots of Synchron Acetaminophen Reagent (M703276 & M702524). Customers were also instructed to contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or, if they are outside the US or Canada, please contact your local Beckman Coulter Representative to discuss replacement options. They were also instructed to complete an |
| Quantity | 7764 test kits |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000494 | SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT Beckman Coulter, Inc., Apr 14, 2000 |