CONSULT(TM) diagnostics hCG CONTROLS Kit recall
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the…
Why was CONSULT(TM) diagnostics hCG CONTROLS Kit recalled?
CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.
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?
Lot/Codes: KN165 (exp. 2017-09), KN169 (exp. 2017-10), KN171 (exp. 2017-11) and KN177 (exp. 2018-02)
- Product
- CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the…
- Recalling firm
- Biochemical Diagnostics Inc
- Quantity
- Domestic: 4,473 kits
- Distribution
- US Nationwide Distribution
- Recall date
- December 2, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)