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Class 2 Device Recall Access hsTnI (High Sensitivity Troponin I) |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
August 09, 2021 |
Create Date |
October 06, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0032-2022 |
Recall Event ID |
88559 |
510(K)Number |
K172787 K172783
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Product Classification |
Immunoassay method, troponin subunit - Product Code MMI
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Product |
Access hsTnI High Sensitivity Troponin I, REF B52699
Access Immunoassay System REAGENT PACK
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Code Information |
Catalog Number:B52699 Lot Number / UDI Code: 921491 / (01)15099590693183(17)201130(11)191201(10)921491; 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; 124235 / (01)15099590693183(17)220228(11)210228(10)124235; 124339 / (01)15099590693183(17)220228(11)210228(10)124339; 922898 / (01)15099590693183(17)220228(11)210228(10)922898; 124340 / (01)15099590693183(17)220331(11)210331(10)124340; 124348 / (01)15099590693183(17)220430(11)210430(10)124348; 124353 / (01)15099590693183(17)220430(11)210430(10)124353; 124688 / (01)15099590693183(17)220430(11)210430(10)124688; 124354 / (01)15099590693183(17)220531(11)210531(10)124354; 124355 / (01)15099590693183(17)220630(11)210630(10)124355; 124356 / (01)15099590693183(17)220630(11)210630(10)124356; 124357 / (01)15099590693183(17)220630(11)210630(10)124357; |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 250 S Kraemer Blvd Brea CA 92821-6232
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For Additional Information Contact |
Annette Hellie 714-831-7388
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Manufacturer 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.
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FDA Determined Cause 2 |
Unknown/Undetermined by firm |
Action |
During the week of 08/09/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via mail or email informing customer of possible carryover with in-use, open (punctured) hsTnI reagent packs, and the impact of carryover on patient samples that are tested from the same reagent pack as a sample with a high cardiac troponin (cTnI) concentration >270,000 pg/mL (ng/L), or the carryover may also impact a different reagent pack. Clinical carryover can affect the results of all subsequent samples that are tested from the affected pack.
Customer are instructed to:
- If an hsTnI result >270,000 pg/mL (ng/L) are observed, perform the following steps:
1. Remove and discard all open Access hsTnI reagent packs.
For customers in the United States, if replacement products are needed, complete the attached Replacement Order Form and email to askbeckman@beckman.com or fax to (866) 294-7850 OR Call Client Services at (800) 526-3821.
2. Load a single Access hsTnI reagent pack.
3. Run the current low level hsTnI QC on all reagent pipettors configured for hsTnI to verify that there is no further carryover.
NOTE: UniCel DxI operators can test all configured reagent pipettors by setting up a QC file as outlined in Appendix A (included with the recall notice).
4. If the QC result is within the laboratory s defined ranges for each pipettor configured, repeat each positive hsTnI sample that was tested after the >270,000 pg/mL (ng/L) cTnI sample and then continue normal operation. Load additional reagent packs if it is appropriate for the laboratory s testing requirements.
5. If the QC result are not within the acceptable range, contact the Recalling Firm's Customer Technical Support for further assistance.
Additional instructions:
- Download the most current version of the hsTnI reagent -nstructions for Use (IFU) from the Recalling Firm's website. Update laboratory procedures as appropriate.
-Share this information with laboratory staff and retain this not |
Quantity in Commerce |
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, 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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