Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 24, 2012
AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving processes. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including the detection of the presence of ad
The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the AutoMate 2500 Family (pre…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Beckman Coulter Inc. recalled AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200… - a moderate-severity action.
AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200… was recalled by Beckman Coulter Inc. in October 24, 2012. Reason: The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labe…. Check the official notice for the remedy. Verify recall #Z-0056-2013 with the FDA Devices before acting.
The recall
Beckman Coulter Inc. issued this moderate-severity FDA Devices recall-The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labe….
- Moderate
- severity level
- 468 units
- affected scope
- Class II
- classification
- October 24, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0056-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0056-2013) was formally reported on October 24, 2012, with the manufacturer initiating the action on April 11, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Beckman Coulter Inc. is listed as the recalling firm, operating out of Brea, CA. Federal records list the affected scope as 468 units total (51 units in US).
The documented reason for this recall is: The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the AutoMate 2500 Family (previously referred to as OLA2500 Systems) … Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and the following countries: Argentina Australia Austria Belarus Belgium China Croatia Czech Republic Denmark Finland France Germany Hungary India Ireland Israel…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
468 units total (51 units in US)
Related Recalls
6
3 from same agency
Product description
AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving processes. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including the detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.
Reason for recall
The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the AutoMate 2500 Family (previously referred to as OLA2500 Systems) units which can cause misidentification of a sample when software versions lower than version 4.1 is used.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0056-2013 |
| Date reported | October 24, 2012 |
| Date initiated | April 11, 2012 |
| Recalling firm | Beckman Coulter Inc. |
| Firm location | Brea, CA |
| Affected scope | 468 units total (51 units in US) |
| Distribution | Worldwide Distribution - USA (nationwide) and the following countries: Argentina Australia Austria Belarus Belgium China Croatia Czech Republic Denmark Finland France Germany Hungary India Ireland Israel Italy Japan Kore… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0056-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving processes. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including the detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.. Recalled by Beckman Coulter Inc.. Units affected: 468 units total (51 units in US).
Why was this product recalled? ▼
The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the AutoMate 2500 Family (previously referred to as OLA2500 Systems) units which can cause misidentification of a sample when software versions lower than version 4.1 is used.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 24, 2012. Severity: Moderate. Recall number: Z-0056-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and the following countries: Argentina Australia Austria Belarus Belgium China Croatia Czech Republic Denmark Finland France Germany Hungary India Ireland Israel Italy Japan Korea, Republic of Kuwait Macao Malaysia Netherlands New Zealand Norway Panama Russian Federation Slovakia Slovenia South Africa Spain Sweden Switzerland Turkey United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0056-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 24, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.