Reported May 31, 2017 · Terminated
Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass…
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
- Chemistry Controls Level I and II LEVlAmber glass vial w/PP white plastic cap
- LEV2Amber glass vial w/PP black plastic cap
- Lot codes and dates
- Model Number(s)C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II)
- Amount recalled
- 132919 Vol vials
Where it was sold
- Nationwide
Why it was recalled
The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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