Z-1798-2018 Class II Terminated
FDA device recall Z-1798-2018 was initiated by Inpeco S.A. on Feb 13, 2018 and is designated Class II. Reason for recall: Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients. The recall status is terminated (terminated Apr 3, 2019). Affected quantity: 18.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Feb 13, 2018
- Termination Date
- Apr 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18
Product Description
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Reason for Recall
Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.
Distribution Pattern
Distributors in 2 states: NY and IL.
Code Information
Serial Numbers: Accelerator a3600 - ACP.150 ACP.185 ACP.186 ACP.192 ACP.202 ACP.214 FlexLab - FLX.0165 FLX.0127 FLX.0128 FLX.0133 FLX.0157 FLX.0160 FLX.0181 Aptio Automation - AP2.0054 AP2.0056 AP2.0060 AP2.0078 AP2.0095 Part Numbers of impacted sample tube carriers: 721501001 for 43 mm carriers, and 0A00006957 for 40 mm carriers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1798-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026