FDA Device recall Z-0087-2022
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
- FDA Device
- Class II
- ongoing
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class II recall of FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.) by Inpeco, citing the Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0087-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-10 |
| Published | 2021-10-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Inpeco |
| Distribution | US |
Product
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Reason
The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.
Identifiers
| code_info | Impacted Module: ADVIA Centaur XP/XPT Interface Module, Part No. FLX-021-00; FLX-021-10; APT-021-00 Serial numbers:…Impacted Module: ADVIA Centaur XP/XPT Interface Module, Part No. FLX-021-00; FLX-021-10; APT-021-00 Serial numbers: ***FLEXLAB*** FLX.0109 FLX.0127 FLX.0128 FLX.0129 FLX.0132 FLX.0133 FLX.0139 FLX.0146 FLX.0147 FLX.0149 FLX.0151 FLX.0153 FLX.0154 FLX.0156 FLX.0157 FLX.0159 FLX.0160 FLX.0162 FLX.0165 FLX.0166 FLX.0167 FLX.0169 FLX.0170 FLX.0172 FLX.0173 FLX.0174 FLX.0179 FLX.0180 FLX.0182 FLX.0191 FLX.0192 FLX.0193 FLX.0194 FLX.043 FLX.069 FLX.085 FLX.086 FLX.087 FLX.093 FLX.097 ***ACCELERATOR a3600*** ACP.334 ***APTIO AUTOMATION*** AP2.0002 AP2.0003 AP2.0004 AP2.0005 AP2.0006 AP2.0007 AP2.0008 AP2.009 AP2.0010 AP2.0011 AP2.0012 AP2.0014 AP2.0015 AP2.0016 AP2.0017 AP2.0018 AP2.0019 AP2.0022 AP2.0023 AP2.0024 AP2.0025 AP2.0026 AP2.0027 AP2.0028 AP2.0029 AP2.0031 AP2.0032 AP2.0033 AP2.0035 AP2.0037 AP2.0038 AP2.0039 AP2.0040 AP2.0041 AP2.0043 AP2.0045 AP2.0046 AP2.0047 AP2.0048 AP2.0049 AP2.0050 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0087-2022%22
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