Reported Oct 24, 2018 · Terminated
"Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in…
Helena Laboratories, Inc.
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: Helena Laboratories, Inc. · 1530 Lindbergh Dr · Beaumont, TX · 77707-4131
Is this the product you have?
- "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen
- in citrated human plasma Contains96
- Protein S
Ag Microwells3 x 0.5mL ELISA Reference Plasma1x12 mL Protein S Conjugate Solution1 x 60mL Sample Diluent1 x 13mL Substrate1 x 15mL Stopping Solution1 x 30mL Phosphate Buffered Saline1 x 2mL Free Protein S
- Reagent FOR IN-VITRO DIAGNOSTIC USE LOT3-16- 5292
- EXP2018-01-26 HELENA LABORATORIES BEAUMONT, TX Outer labeling
- of Substrate (brown bottle and cap)"Substrate 13 mL" FOR IN-VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES Beaumont, Tx "2161421
- EXP2018-01-26" Outer Labeling of Protein S Conjugate bottle (clear bottle and cap
- red liquid)"Protein S Conjugate 12 mL" FOR IN-VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES Beaumont, Tx "2161421
- EXP2018-01-26"
- Lot codes and dates
- 3-16-5292
- UDIPrimary DI - M52552920
- Amount recalled
- 3 kits
Why it was recalled
Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate.
This product could cause temporary or reversible health problems — stop using it.
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