Reported Oct 20, 2021 · Ongoing
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Inpeco S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Inpeco S.A. · Via San Gottardo 10 · Lugano, N/A · N/A
Is this the product you have?
- FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
- Lot codes and dates
- Impacted Module
ADVIA Centaur XP/XPT Interface ModulePart No. FLX-021-00FLX-021-10
- APT-021-00 Serial numbers***FLEXLAB******ACCELERATOR a3600*** ACP.334 ***APTIO AUTOMATION***
FLX.0109FLX.0127FLX.0128FLX.0129FLX.0132FLX.0133FLX.0139FLX.0146FLX.0147FLX.0149FLX.0151FLX.0153FLX.0154FLX.0156FLX.0157FLX.0159FLX.0160FLX.0162FLX.0165FLX.0166FLX.0167FLX.0169FLX.0170FLX.0172FLX.0173FLX.0174FLX.0179FLX.0180FLX.0182FLX.0191FLX.0192FLX.0193FLX.0194FLX.043FLX.069FLX.085FLX.086FLX.087FLX.093FLX.097
221 of 221 codes
AP2.0002AP2.0003AP2.0004AP2.0005AP2.0006AP2.0007AP2.0008AP2.009AP2.0010AP2.0011AP2.0012AP2.0014AP2.0015AP2.0016AP2.0017AP2.0018AP2.0019AP2.0022AP2.0023AP2.0024AP2.0025AP2.0026AP2.0027AP2.0028AP2.0029AP2.0031AP2.0032AP2.0033AP2.0035AP2.0037AP2.0038AP2.0039AP2.0040AP2.0041AP2.0043AP2.0045AP2.0046AP2.0047AP2.0048AP2.0049AP2.0050AP2.0051AP2.0052AP2.0053AP2.0054AP2.0055AP2.0057AP2.0058AP2.0059AP2.0061AP2.0062AP2.0063AP2.0064AP2.0065AP2.0066AP2.0067AP2.0070AP2.0075AP2.0076AP2.0077
- Impacted Module
- Amount recalled
- 262 total, 52 US
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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