Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported August 14, 2019
Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus ana
The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Polymer Technology Systems, Inc. recalled Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 57… - a low-severity action.
Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 57… was recalled by Polymer Technology Systems, Inc. in August 14, 2019. Reason: The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD …. Check the official notice for the remedy. Verify recall #Z-2158-2019 with the FDA Devices before acting.
The recall
Polymer Technology Systems, Inc. issued this low-severity FDA Devices recall-The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD ….
- Low
- severity level
- Class III
- classification
- August 14, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2158-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2158-2019) was formally reported on August 14, 2019, with the manufacturer initiating the action on June 7, 2019. It is classified under Low severity (Class III), with a current status of Terminated. Polymer Technology Systems, Inc. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as 559 vials.
The documented reason for this recall is: The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan. 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
559 vials
Related Recalls
6
3 from same agency
Product description
Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.
Reason for recall
The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2158-2019 |
| Date reported | August 14, 2019 |
| Date initiated | June 7, 2019 |
| Recalling firm | Polymer Technology Systems, Inc. |
| Firm location | Indianapolis, IN |
| Affected scope | 559 vials |
| Distribution | Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan |
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-2158-2019) 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? ▼
Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.. Recalled by Polymer Technology Systems, Inc.. Units affected: 559 vials.
Why was this product recalled? ▼
The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2019. Severity: Low. Recall number: Z-2158-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2158-2019) 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 August 14, 2019. 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.