Open, Classified

Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

FDA Recall Z-0032-2022 · Posted None

Recall StatusOpen, Classified

Product CodeMMI

Date Initiated2021-08-09

Product Quantity293,640 kits

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.

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 [email protected] 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

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172787Access hsTnlBeckman Coulter, Inc. · 2018-06-14 K172783Access hs TnlBeckman Coulter, Inc. · 2018-06-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.