Reported Jul 5, 2017 · Terminated
Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK…
Medtest Holdings, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Medtest Holdings, Inc. · 5449 Research Dr · Canton, MI · 48188-2261
Is this the product you have?
- Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution
- Intended UseFor the kinetic quantitative determination of creatine kinase activity in serum
- Lot codes and dates
- Models
C7522HC422HC722HC922. Lot#'s: 020902029902 R1029902 R2029903113204129403209001. Exp dates 7/2012 to 9/2013
- Models
- Amount recalled
- 319.922 L
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Linear performance information in product insert does not match that listed in the approved premarket notification
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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