Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported July 5, 2017
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 Use: For the kinetic quantitative determination of creatine kinase activity in serum.
Linear performance information in product insert does not match that listed in the approved premarket notification
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtest Holdings, Inc. recalled Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two re… - a low-severity action.
Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two re… was recalled by Medtest Holdings, Inc. in July 5, 2017. Reason: Linear performance information in product insert does not match that listed in the approved premarket notific…. Check the official notice for the remedy. Verify recall #Z-2650-2017 with the FDA Devices before acting.
The recall
Medtest Holdings, Inc. issued this low-severity FDA Devices recall-Linear performance information in product insert does not match that listed in the approved premarket notific….
- Low
- severity level
- Class III
- classification
- July 5, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2650-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2650-2017) was formally reported on July 5, 2017, with the manufacturer initiating the action on October 19, 2011. It is classified under Low severity (Class III), with a current status of Terminated. Medtest Holdings, Inc. is listed as the recalling firm, operating out of Canton, MI. Federal records list the affected scope as 319.922 L.
The documented reason for this recall is: Linear performance information in product insert does not match that listed in the approved premarket notification Distribution data in the federal record shows the product reached: Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
319.922 L
Related Recalls
6
3 from same agency
Product description
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 Use: For the kinetic quantitative determination of creatine kinase activity in serum.
Reason for recall
Linear performance information in product insert does not match that listed in the approved premarket notification
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2650-2017 |
| Date reported | July 5, 2017 |
| Date initiated | October 19, 2011 |
| Recalling firm | Medtest Holdings, Inc. |
| Firm location | Canton, MI |
| Affected scope | 319.922 L |
| Distribution | Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2650-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 Use: For the kinetic quantitative determination of creatine kinase activity in serum.. Recalled by Medtest Holdings, Inc.. Units affected: 319.922 L.
Why was this product recalled? ▼
Linear performance information in product insert does not match that listed in the approved premarket notification
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 5, 2017. Severity: Low. Recall number: Z-2650-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2650-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 5, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.