Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 21, 2013
Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry System Refurbished, 3) VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), VITROS 5600 Integrated System.
Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ortho-Clinical Diagnostics recalled Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890,… - a moderate-severity action.
Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890,… was recalled by Ortho-Clinical Diagnostics in August 21, 2013. Reason: Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to b…. Check the official notice for the remedy. Verify recall #Z-1948-2013 with the FDA Devices before acting.
The recall
Ortho-Clinical Diagnostics issued this moderate-severity FDA Devices recall-Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to b….
- Moderate
- severity level
- Class II
- classification
- August 21, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1948-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1948-2013) was formally reported on August 21, 2013, with the manufacturer initiating the action on June 6, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Ortho-Clinical Diagnostics is listed as the recalling firm, operating out of Rochester, NY. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, …. 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
Unknown
Related Recalls
6
3 from same agency
Product description
Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry System Refurbished, 3) VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), VITROS 5600 Integrated System.
Reason for recall
Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1948-2013 |
| Date reported | August 21, 2013 |
| Date initiated | June 6, 2013 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Firm location | Rochester, NY |
| Affected scope | Not disclosed |
| Distribution | Worldwide Distribution - USA Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, … |
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-1948-2013) 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? ▼
Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry System Refurbished, 3) VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), VITROS 5600 Integrated System.. Recalled by Ortho-Clinical Diagnostics.
Why was this product recalled? ▼
Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2013. Severity: Moderate. Recall number: Z-1948-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Puerto Rico and the countries of Mexico, Singapore, Venezuela, England, Germany, Italy & Spain..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1948-2013) 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 August 21, 2013. 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.