Inpeco Centrifuge Module Recall for Potential Unbalanced Load Damage
Inpeco S.A. is recalling 23 Abbott Accelerator a3600 Centrifuge Modules because a loading algorithm defect may cause unbalanced loads that could damage the equipment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves equipment damage from unbalanced loads, which is a risk-of-harm product issue where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Inpeco S.A. is recalling 23 units of the Abbott Accelerator a3600 Centrifuge Module. The affected units are identified by specific serial numbers and firmware versions, including P/N FLX-202 with firmware versions CM_1-7-0.H86, xCMd_2-5-0.elf, CM_1-7-1.H86, or xCMd_2-5-1-849fad9.elf.
The recall is due to a defect in the tube loading algorithm. This algorithm may lead to unbalanced loads, which could result in damage to the centrifuge. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The affected units were distributed worldwide, including in numerous US states such as Ohio, New York, Virginia, Pennsylvania, Texas, and California. Users of these devices should contact Inpeco S.A. for instructions on how to resolve the issue.
The recalled product
- Product
- Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
- Manufacturer
- Inpeco S.A.
- Affected units
- 23
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: ACP.357
- ACP.388
- ACP.396
- ACP.397
- ACP.399
- ACP.400
- ACP.402
- ACP.404
- ACP.405
- ACP.407
- ACP.408
- ACP.409
- ACP.410
- ACP.412
- ACP.413
- ACP.416
- ACP.417
- ACP.418
- ACP.419
- ACP.420
Distribution
Part of a larger recall action
This product is one of 3 recalled by Inpeco S.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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