Cairn Diagnostics Recall 87186
Description: 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.
Cairn Diagnostics Recall 87186 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1128-2021 |
| Event ID | 87186 |
| Event Description | 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC. |
| Quantity | 103 kits |
| Recall Reason | Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates |
| Device Classification | 20210224 |
| Device Code Info | Lot Codes: K021-021R, K021-022 |
| Center Classification Date | 20210216 |
| Recall Initiation Date | 20210108 |
| Recalling Firm | Cairn Diagnostics |
| Initial Notification | Telephone |
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