Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 18, 2017
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuvette segment holds 11 cuvettes. With 9 segments, the reaction carousel holds 99 cuvettes. The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The system is designed to perform automated chemistry te
There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Abbott Laboratories, Inc recalled ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abb… - a moderate-severity action.
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abb… was recalled by Abbott Laboratories, Inc in October 18, 2017. Reason: There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached s…. Check the official notice for the remedy. Verify recall #Z-0011-2018 with the FDA Devices before acting.
The recall
Abbott Laboratories, Inc issued this moderate-severity FDA Devices recall-There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached s….
- Moderate
- severity level
- Class II
- classification
- October 18, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0011-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0011-2018) was formally reported on October 18, 2017, with the manufacturer initiating the action on January 15, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Abbott Laboratories, Inc is listed as the recalling firm, operating out of Irving, TX. Federal records list the affected scope as 1,385 cuvette segments.
The documented reason for this recall is: There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia & Herzegovina, Brazil, …. 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
1,385 cuvette segments
Related Recalls
6
3 from same agency
Product description
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuvette segment holds 11 cuvettes. With 9 segments, the reaction carousel holds 99 cuvettes. The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The system is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
Reason for recall
There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0011-2018 |
| Date reported | October 18, 2017 |
| Date initiated | January 15, 2015 |
| Recalling firm | Abbott Laboratories, Inc |
| Firm location | Irving, TX |
| Affected scope | 1,385 cuvette segments |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria Bur… |
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-0011-2018) 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? ▼
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuvette segment holds 11 cuvettes. With 9 segments, the reaction carousel holds 99 cuvettes. The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The system is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.. Recalled by Abbott Laboratories, Inc. Units affected: 1,385 cuvette segments.
Why was this product recalled? ▼
There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 18, 2017. Severity: Moderate. Recall number: Z-0011-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria Burkina Faso, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gaza & Jericho, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malawi, Malaysia, Maldives, Mali, Mauritania, Mexico, Morocco, Netherlands, New Zealand, Nigeria, North Yemen, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia (CIS), Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, St. Lucia, Sweden, Switzerland, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks & Caicos, UAE, Uganda, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, and Zimbabwe..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0011-2018) 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 18, 2017. 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.