Beckman Coulter Inc. Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.
Brand
Beckman Coulter Inc.
Lot Codes / Batch Numbers
Catalog Number: 33880, all lots.
Products Sold
Catalog Number: 33880; all lots.
Beckman Coulter Inc. is recalling Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) due to The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
Recommended Action
Per FDA guidance
On 04/30/2019, an Urgent Medical Device Letter was sent via mail to affected consignees. Customers were instructed to access the updated Instructions for Use (IFU) Limitations and Interferences sections for the six affected Access immunoassays on the firm's website. Additionally they ask customers to do the following: 1) Share the information with laboratory staff and retain the notification as part of their laboratory Quality System documentation. If any of the affected product(s) have been forwarded to another laboratory, they are to provide them with a copy of the Urgent Medical Device Recall letter. 2) Respond within 10 days either electronically (if received communication via email) or manually (complete and return an enclosed Response Form). If there are any questions regarding the notice, contact the Customer Support Center: website: http://www.beckmancoulter.com By phone: call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact the local firm representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR
Page updated: Jan 10, 2026