Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 13, 2021
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Beckman Coulter Inc. recalled Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT… - a moderate-severity action.
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT… was recalled by Beckman Coulter Inc. in October 13, 2021. Reason: Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may…. Check the official notice for the remedy. Verify recall #Z-0032-2022 with the FDA Devices before acting.
The recall
Beckman Coulter Inc. issued this moderate-severity FDA Devices recall-Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may….
- Moderate
- severity level
- Class II
- classification
- October 13, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0032-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0032-2022) was formally reported on October 13, 2021, with the manufacturer initiating the action on August 9, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Beckman Coulter Inc. is listed as the recalling firm, operating out of Brea, CA. Federal records list the affected scope as 293,640 kits.
The documented reason for this recall is: Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominant… Distribution data in the federal record shows the product reached: U.S.: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, NC, ND, NE, NV, NJ, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, VA, WA, WI, WV, and WY O.U.S.: Al…. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
293,640 kits
Related Recalls
6
3 from same agency
Product description
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Reason for recall
Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0032-2022 |
| Date reported | October 13, 2021 |
| Date initiated | August 9, 2021 |
| Recalling firm | Beckman Coulter Inc. |
| Firm location | Brea, CA |
| Affected scope | 293,640 kits |
| Distribution | U.S.: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, NC, ND, NE, NV, NJ, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, VA, WA, WI, WV, and WY O.U.S.: Algeria, Andorra, Aust… |
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-0032-2022) 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? ▼
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK. Recalled by Beckman Coulter Inc.. Units affected: 293,640 kits.
Why was this product recalled? ▼
Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 13, 2021. Severity: Moderate. Recall number: Z-0032-2022.
Where was the recalled product distributed? ▼
Distribution: U.S.: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, NC, ND, NE, NV, NJ, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, VA, WA, WI, WV, and WY O.U.S.: Algeria, Andorra, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, China, Croatia, Cura¿ao, Czech Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Niger, Nigeria, Norway, Oman, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Swaziland, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vietnam, Yemen, and Zimbabwe.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0032-2022) 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 October 13, 2021. 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.