CLASS II Device recall · Reported 9 Sep 2015 · FDA Enforcement Report
G6PD Controls Kit configuration: ml recalled by Pointe Scientific
Pointe Scientific is recalling Pointe Scientific G6PD Controls Kit configuration: ml (2 vials each of Level 1, Level 2, distributed nationwide in the US. The recall was initiated on 19 May 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2487-2015
- FDA event ID
- 71988
- Recalling firm
- Pointe Scientific, Canton, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 May 2015
- FDA classified
- 31 Aug 2015
- Reported
- 9 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 19 May 2015 | Recall initiated by company | |
| 31 Aug 2015 | Classified by FDA | +104 days |
| 9 Sep 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber 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.
Where it was distributed
Worldwide distribution: US (nationwide) including states of: PA, CA, KY, FL, NJ, DE, MI, MN,and IL; and countries of: United Arab Emirates, Austria, Italy, Israel, Greece, and Australia.
Nationwide CaliforniaDelawareFloridaIllinoisKentuckyMichiganMinnesotaNew JerseyPennsylvania
Questions about this recall
Is G6PD Controls Kit configuration: ml (2 vials each of Level 1, Level 2 and Level . Also recalled?
Yes. Pointe Scientific recalled G6PD Controls Kit configuration: ml (2 vials each of Level 1, Level 2 and Level . Also on 19 May 2015. The recall is Class II and its status is Terminated. Recall number Z-2487-2015.
Why was it 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.
Which lots are affected?
Lot: 505801 Expiration date: 2015-11 catalog numbers: G7583-CTL 7-G7583-CTL-L1 7-G7583-CTL-L2 7-G7583-CTL-L3
Where was it sold?
Worldwide distribution: US (nationwide) including states of: PA, CA, KY, FL, NJ, DE, MI, MN,and IL; and countries of: United Arab Emirates, Austria, Italy, Israel, Greece, and Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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