Abbott Laboratories, Inc ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
Brand
Abbott Laboratories, Inc
Lot Codes / Batch Numbers
Serial numbers C800174 through C800346 and the following Serial numbers: C800072, C800122, C800131, and C800142
Products Sold
Serial numbers C800174 through C800346 and the following Serial numbers: C800072, C800122, C800131, and C800142
Abbott Laboratories, Inc is recalling ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medic due to Process change in the manufacturing of the AC/DC driver board used on the analyzer may result in one or more of the solid state relays to fail during . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Process change in the manufacturing of the AC/DC driver board used on the analyzer may result in one or more of the solid state relays to fail during use.
Recommended Action
Per FDA guidance
The firm initiated the recall by Technical Service Bulletin sent to affected customers. The AC/DC boards will be replaced on each analyzer by a 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 noticePage updated: Jan 10, 2026