The Recall Desk
ModerateFDA (Devices)·Z-0032-2022·Announced 2021-10-13

Beckman Coulter Troponin I Reagent Packs Recalled Due to Sample Contamination

Beckman Coulter is recalling 293,640 Access hsTnI High Sensitivity Troponin I reagent packs due to sample carryover contamination occurring with very high concentration samples, potentially affecting test accuracy.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Class II recall with no reported illnesses or injuries. The contamination occurs only with very high concentration samples exceeding 270,000 pg/mL, representing low-risk contamination in a precautionary recall scenario.

Plain-English summary

Beckman Coulter Inc. is recalling 293,640 units of Access hsTnI High Sensitivity Troponin I reagent packs (Catalog Number B52699) distributed across the United States, Puerto Rico, Guam, and numerous international markets. The reagent packs are used in the Access Immunoassay System for cardiac troponin testing.

The recall stems from a contamination issue discovered through customer feedback. When samples with cardiac troponin I concentrations exceeding 270,000 pg/mL are tested, sample carryover can occur into the reagent pack, primarily contaminating the particle well via the probe. This carryover can compromise the accuracy of test results. The extent of contamination depends on sample concentration and the frequency of high-concentration samples processed.

No illnesses or injuries have been reported. The contamination affects only samples at extreme concentration levels above the specified threshold. Healthcare facilities and laboratories should review their records to identify affected lots and implement appropriate corrective actions in consultation with the manufacturer.

The recalled product

Product
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Diagnostic Reagent
Hazard
Affected units
293,640

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 921638 / (01)15099590693183(17)201231(11)200101(10)921638
  • 921631 / (01)15099590693183(17)210131(11)200201(10)921631
  • 921750 / (01)15099590693183(17)210131(11)200201(10)921750
  • 921805 / (01)15099590693183(17)210228(11)200229(10)921805
  • 921831 / (01)15099590693183(17)210331(11)200331(10)921831
  • 921943 / (01)15099590693183(17)210430(11)200430(10)921943
  • 922000 / (01)15099590693183(17)210531(11)200531(10)922000
  • 922039 / (01)15099590693183(17)210630(11)200630(10)922039
  • 922040 / (01)15099590693183(17)210731(11)200731(10)922040
  • 922062 / (01)15099590693183(17)210731(11)200731(10)922062
  • 922145 / (01)15099590693183(17)210831(11)200831(10)922145
  • 922146 / (01)15099590693183(17)210930(11)200930(10)922146
  • 922338 / (01)15099590693183(17)210930(11)200930(10)922338
  • 922440 / (01)15099590693183(17)211031(11)201031(10)922440
  • 922545 / (01)15099590693183(17)211031(11)201031(10)922545
  • 922547 / (01)15099590693183(17)211130(11)201130(10)922547
  • 922713 / (01)15099590693183(17)211231(11)201231(10)922713
  • 922714 / (01)15099590693183(17)211231(11)201231(10)922714
  • 922722 / (01)15099590693183(17)220131(11)210131(10)922722
  • 922897 / (01)15099590693183(17)220131(11)210131(10)922897

Distribution

Distributed in 46 states:

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