Recall Z-1799-2020 ยท DIS Enzyme Immunoassay, Barbiturate
Beckman Coulter Inc.
SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of barbiturates in human urine at a cutoff value of 200 ng/mL The BARB assay provides a rapid screening procedure for determining th
| Date | Jun 12, 2019 |
| Status | Terminated |
| Reason | The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain compounds in urine may result in false positive or false negative results. |
| Root cause | Under Investigation by firm |
| Action | On 06/12/2019, an Urgent Medical Device Recall Letter was sent to customers via first class mail and/or email informing them that the firm has identified, through study results, that cross-reactivity testing may not meet the claims indicated in the Barbiturates Chemistry Information Sheet (CIS). Customers were informed that the presence of the following compounds in urine may lead to false negative results: Barbital at a concentration of 1500 to ~1700 ng/mL; Butabarbital at a concentration of 250 to ~300 ng/mL; Butalbital at a concentration of 400 to ~500 ng/mL; Diallybarbital at a concentr |
| Quantity | 10,145 units |
| Distribution | Worldwide distribution - US Nationwide distribution and to multiple countries. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944075 | CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST Beckman Instruments, Inc., Dec 29, 1994 |