CLASS III Device recall · Reported 23 Sep 2015 · FDA Enforcement Report
Creatinine Reagent recalled by Pointe Scientific
Pointe Scientific is recalling Pointe Scientific Creatinine Reagent, distributed nationwide in the US. The recall was initiated on 12 Dec 2014 and the FDA has classified it as Class III.
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-2773-2015
- FDA event ID
- 71974
- Recalling firm
- Pointe Scientific, Canton, MI
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Dec 2014
- FDA classified
- 16 Sep 2015
- Reported
- 23 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Test Kits & Diagnostics
Timeline
| 12 Dec 2014 | Recall initiated by company | |
| 16 Sep 2015 | Classified by FDA | +278 days |
| 23 Sep 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.
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 Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.
Where it was distributed
Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines.
Questions about this recall
Is Creatinine Reagent recalled?
Yes. Pointe Scientific recalled Creatinine Reagent on 12 Dec 2014. The recall is Class III and its status is Terminated. Recall number Z-2773-2015.
Why was it recalled?
Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.
Which lots are affected?
C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03
Where was it sold?
Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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