Recall Z-2213-2011 ยท GGK Products, Red-Cell Lysing Products
Beckman Coulter Inc.
COULTER LYSE S III diff Lytic Part Number: 8546796. COULTER LYSE S III diff Lytic Reagent For use as an erythrocyte lytic agent for the quantitative determination of hemoglobin and for leukocyte counting and sizing on COULTER GEN S, MAXM, HmX, LH500, LH 750, and LH 780 hematology analyzers. Use with only ISOTON III or LH Series diluent. Refer to your instrument product manuals and/or online help,
| Date | May 19, 2011 (initiated Dec 28, 2010) |
| Status | Terminated |
| Reason | The recall was initiated by Beckman Coulter because the COULTER LYSE III diff Lytic Reagent Lot number 101554F was released for distribution to customers between November 17 and December 1, 2010 prior to completion of QC testing. |
| Root cause | Pending |
| Action | Beckman Coulter sent a Product Corrective Action ( PCA) letter dated December 28, 2010, to all affected consignees with an attached PCA Response form via US Postal Service for US Customers) who purchased the Coulter Lyse S III diff Lytic Lot # 101554F. The letter provides customers with an explanation of the problem identified and an action to be taken. If customers currently had any of the lot mentioned above in their laboratory, they were asked to discontinue use and discard remaining product according to their laboratory chemical safety procedures. And to complete and return the enclo |
| Quantity | 1,296 units |
| Distribution | Worldwide Distrubution-- USA ( nationwide) including states of : AL, AR, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, RI, SC, TN, TX, VA, WI, & WV and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.