Reported Apr 21, 2021 · Terminated
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from…
Becton Dickinson & Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton Dickinson & Co. · 7 Loveton Cir · Sparks, MD · 21152-9212
Is this the product you have?
- BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in
- nasopharyngeal specimens Catalog Number444213
- Lot codes and dates
- Lot Numbers/Exp
- DateLot Number Expiration Date
304 of 304 codes
K20-3471/23/2021K20-3481/23/2021K20-3521/24/2021K20-3531/24/2021K20-3541/24/2021K20-3551/25/2021K20-3571/25/2021K20-3561/25/2021K20-3581/26/2021K20-3661/28/2021K20-3671/29/2021K20-3731/30/2021K20-3761/31/2021K20-3771/31/2021K20-3822/1/2021K20-3782/2/2021K20-3792/2/2021K20-3802/3/2021K20-3812/3/2021K20-3852/5/2021K20-3862/6/2021K20-5383/1/2021K20-5763/20/2021K20-5773/20/2021K20-5783/20/2021K20-5653/21/2021K20-5663/21/2021K20-5673/21/2021K20-5683/21/2021K20-5153/24/2021
- K20-636 5/16/2021 K20-637 5/17/2021 UDI382904442132
- Amount recalled
- 21,529 Kits
Where it was sold
- Nationwide
Why it was recalled
BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A partially filled or empty rehydration buffer tube may lead to an Unresolved (UNR) result on the BD MAX" System
This product could cause temporary or reversible health problems — stop using it.
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