1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II recall
1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿…
Why was 1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II recalled?
When testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to approximately 7.40 mIU/mL (IU/L) for patient samples that should have been less than the measuring range of the assay (<2.39 mIU/mL (IU/L)).
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?
Product Codes: 6802220, 6802221; Affected Lot Numbers: 1410, 1420, 1430 (With Expiry Date 17-Jun-2016), Lot Number: 1440 (With Expiry Date 15-Aug-2016, Lot Numbers: 1450, 1460, 1470 (With Expiry Date 17-Aug-2016) and Lot Number 1480 distributed only outside of U.S. (With Expiry Date 30-Sept-2016)
- Product
- 1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 14,780 pieces
- Distribution
- Nationwide Distribution.
- Recall date
- June 1, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)