SYNCHRON Systems Barbiturates Reagent recall
SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800…
Why was SYNCHRON Systems Barbiturates Reagent recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SYNCRHON Systems BARB 1 X 250); Catalog No. 475012; UDI: 15099590223007; Lot Numbers M903174, M902167, M801045, M811093, M809230, M807116, M806172, M805116, M804028, M803040, M802093 and older.
- Product
- SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 10,145 units
- Distribution
- Worldwide distribution - US Nationwide distribution and to multiple countries.
- Recall date
- May 6, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)