Reported Sep 9, 2015 · Terminated
Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold…
Pointe Scientific, 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: Pointe Scientific, Inc. · 5449 Research Dr · Canton, MI · 48188-2261
Is this the product you have?
- Pointe Scientific
- G6PD Controls Kit configuration
6 x 0.5 ml (2 vials each of Level 1Level 2 and Level 3)
- Also sold as individual vials BottleClear
- glass vials CapRubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood
- Lot codes and dates
- Lot505801
- Expiration date2015-11
- catalog numbersG7583-CTL 7-G7583-CTL-L1 7-G7583-CTL-L2 7-G7583-CTL-L3
- Amount recalled
- 2772 total vials (374 kits of 6 vials, 528 invidually sold vials)
Where it was sold
Why it was recalled
A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of the control after reconstitution, which could result in an out of specification result prior to the current reconstitution claim of 7 days. For this reason we suggest discontinuing use of the control set.
This product could cause temporary or reversible health problems — stop using it.
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