Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila FSH Calibrators (LN 9C06-01), for in vitro diagnostic use. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Brand
Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila
Lot Codes / Batch Numbers
Lot # 33362Q100 Expiration Date 11/04/2006
Products Sold
Lot # 33362Q100 Expiration Date 11/04/2006
Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila is recalling FSH Calibrators (LN 9C06-01), for in vitro diagnostic use. due to Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.
Recommended Action
Per FDA guidance
The Device Recall Letter dated September 07, 2006, and Customer Reply Form was sent via Federal Express Priority mail to all customers who received the affected lots.
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
PR
Page updated: Jan 10, 2026