Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported October 31, 2012
Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.
The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thy…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Beckman Coulter Inc. recalled Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. T… - a low-severity action.
Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. T… was recalled by Beckman Coulter Inc. in October 31, 2012. Reason: The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Mul…. Check the official notice for the remedy. Verify recall #Z-0110-2013 with the FDA Devices before acting.
The recall
Beckman Coulter Inc. issued this low-severity FDA Devices recall-The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Mul….
- Low
- severity level
- 6K units
- affected scope
- Class III
- classification
- October 31, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0110-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0110-2013) was formally reported on October 31, 2012, with the manufacturer initiating the action on December 15, 2011. It is classified under Low severity (Class III), 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 5746 units total (2729 units in US).
The documented reason for this recall is: The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thyroxine (T4) Reagent Calibrator Diskettes. Distribution data in the federal record shows the product reached: Worldwide distribution: USA (Nationwide) and Internationally to: Afghanistan Angola Australia Bangladesh Belgium Bhutan Brazil Brunei Darussalam Bulgaria Canada China Colombia Costa Rica Cote d'Ivoire Czech Republic Den…. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5746 units total (2729 units in US)
Related Recalls
6
3 from same agency
Product description
Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.
Reason for recall
The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thyroxine (T4) Reagent Calibrator Diskettes.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0110-2013 |
| Date reported | October 31, 2012 |
| Date initiated | December 15, 2011 |
| Recalling firm | Beckman Coulter Inc. |
| Firm location | Brea, CA |
| Affected scope | 5746 units total (2729 units in US) |
| Distribution | Worldwide distribution: USA (Nationwide) and Internationally to: Afghanistan Angola Australia Bangladesh Belgium Bhutan Brazil Brunei Darussalam Bulgaria Canada China Colombia Costa Rica Cote d'Ivoire Czech Republic Denmark Ecuador Egypt E… |
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-0110-2013) 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? ▼
Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.. Recalled by Beckman Coulter Inc.. Units affected: 5746 units total (2729 units in US).
Why was this product recalled? ▼
The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thyroxine (T4) Reagent Calibrator Diskettes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2012. Severity: Low. Recall number: Z-0110-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA (Nationwide) and Internationally to: Afghanistan Angola Australia Bangladesh Belgium Bhutan Brazil Brunei Darussalam Bulgaria Canada China Colombia Costa Rica Cote d'Ivoire Czech Republic Denmark Ecuador Egypt El Salvador Eritrea Ethiopia Finland France French Polynesia Germany Ghana Greece Guatemala Hong Kong India Indonesia Ireland Israel Italy Japan Jordan Kenya Kuwait Lebanon Lesotho Libyan Arab Jamahiriya Lithuania Macao Malawi Malaysia Mexico Morocco Namibia Netherlands New Zealand Nigeria Oman Pakistan Panama Paraguay Philippines Poland Puerto Rico Qatar Reunion Romania Russian Federation Rwanda Saudi Arabia Serbia Singapore Slovakia South Africa Spain Swaziland Sweden Switzerland Taiwan Thailand Tunisia Turkey Uganda United Arab Emirates United Kingdom Viet Nam Zambia Zimbabwe.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0110-2013) 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 31, 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.